Cleared Traditional

K161597 - Tyber Medical BioTy® Nanotopography Trauma Screw

K161597 is an FDA 510(k) clearance for Tyber Medical BioTy Nanotopography Trau..., manufactured by Tyber Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K161597 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2016
Decision
160d
Days
Class 2
Risk

K161597 is an FDA 510(k) clearance for the Tyber Medical BioTy® Nanotopography Trauma Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Morristown, US). The FDA issued a Cleared decision on November 16, 2016 after a review of 160 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tyber Medical, LLC devices

FDA 510(k) Submission Details - K161597

510(k) Number K161597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2016
Decision Date November 16, 2016
Days to Decision 160 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 122d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 951
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K161597.
KLS Martin Cannulated Headless Screws
K161259 · KLS-Martin L.P. · Dec 2016
4.0 and 6.5 Cancellous Bone Screw and Washer
K160946 · Smv Scientific · Dec 2016
ToeTac™ 10° Hammertoe Fixation System
K161778 · Restore Surgical, LLC Dba Instratek · Nov 2016
AmorChem Titanium Porous Fixation Device
K160791 · Amorchem Holdings, Inc. · Nov 2016
HammerTech Fixation System
K161449 · Fusion Orthopedics, LLC · Oct 2016
I.B.S. 2.0 Osteosynthesis screw
K160174 · In2bones Sas · Oct 2016